MAUDE Adverse Event Report: ANGIOSCORE, INC ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX); CATHETER, ANGIOPLASTY, CORONARY

Model Number 2200-3015

Device Problems Difficult to Remove (1528); Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 06/10/2016

Event Type  Injury  

Manufacturer Narrative

The patient's dob or age at time of event and weight are unknown.This information was not available from the facility.The angiosculpt device got caught on the coronary artery and additional intervention was performed in order to remove it from the patient, resulting in prolongation of the case.In addition, the complaint stated that there was patient injury (inferior stemi (st-elevation myocardial infarction)).It is unknown if the angiosculpt device caused or contributed to the myocardial infarction as attempts to obtain additional information from the facility has not been successful.Patient information regarding relevant tests/laboratory data or medical history is unknown.This information was not available from the facility.(b)(4).The angiosculpt device was returned for evaluation.Visual inspection found a damaged scoring element.One scoring element ring was lifted and bent from the damaged distal bond and one scoring element ring was bent at the damaged intermediate bond.The shaft was stretched and the support wire was kinked approximately 4 cm proximal to rx port.During retraction, the angiosculpt got stuck inside the coronary artery but was able to be removed with additional intervention.

Event Description

After deflation, the angiosculpt balloon would not come out of the artery.Upon removal, the distal end of the scoring element was deformed.The device was retrieved by placing a guideline (7f) sheath over the top of the angiosculpt balloon.In addition, patient injury (inferior stemi) was noted.

Manufacturer Narrative

A vessel dissection was inadvertently missed at initial reporting.It is possible that the vessel dissection may have caused or contributed to the inferior stemi.

Event Description

A vessel dissection was noted.

Manufacturer Narrative

The patient codes and device codes were not included in the initial mdr.

Manufacturer Narrative

Included patient's age and weight.Included narrative from physician received on 11/05/2019.Included concomitant brand and size.

Event Description

The rca lesion was predilated with a 2.5 x 15 mm angiosculpt balloon to 12 atm and 14 atm.The balloon was deflated and removed easily.Then a 3.0 x 15 mm angiosculpt balloon was inflated to 14 atm and deflated with no issues.During retrieval of the balloon, it got stuck within the vessel in the same position that it had been inflated.With each attempted pull, the guide catheter would deeply intubate into the rca leading to advancement of the bmw guide wire within the posterolateral branch.Multiple attempts were made to dislodge the angiosculpt system, but failed.Eventually after deep intubation with a 7f guideliner catheter, the angiosculpt was able to be retrieved with significant amount of tension.This applied force led to all the equipment being removed from the vessel, including the guide wire.Unfortunately, following removal of the angiosculpt system, there was st elevation in the inferior leads from an occlusive dissection of the posterolateral branch.This was the mechanism for the inferior stemi.After some time, the posterolateral branch was recanalized using a fielder xt-a guide wire loaded onto a corsair microcatheter.The case was completed by deploying the bioabsorbable scaffolds with good result and normal coronary flow.Optical coherence tomography (oct) was performed and showed some calcification in the lesion, but was not extensive.The st elevation resolved, but unfortunately the guide wire had caused a distal perforation which was complicated by a small pericardial effusion that slowly accumulated over a period of days and eventually required pericardiocentesis due to signs of cardiac tamponade.This led to dressler's like inflammatory syndrome and further pericardiocentesis was required some days later and eventually the patient required steroids for 6-12 months to cure the pericardial effusion.Following the initial procedure, the patient was transferred to the coronary care unit for further management.

• Brand Name: ANGIOSCULPT PTCA SCORING BALLOON CATHETER (RX)
• Type of Device: CATHETER, ANGIOPLASTY, CORONARY
• Manufacturer (Section D): ANGIOSCORE, INC; fremont CA
• MDR Report Key: 5827629
• MDR Text Key: 50620048
• Report Number: 3005462046-2016-00019
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): Y
• PMA/PMN Number: P050018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/01/2005,07/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2019
• Device Model Number: 2200-3015
• Device Catalogue Number: 2200-3015
• Device Lot Number: G16040024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2016
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided; 07/11/2016; 11/05/2019
• Supplement Dates FDA Received: 08/24/2016; 01/23/2018; 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT: 0.014" BMW GUIDE WIRE; ASAHI: 7.5F GUIDE CATHETER; TERUMO: 6F INTRODUCER SHEATH; UNK MFG AND SIZE: INTRODUCER SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 88